Description

In this role, you will play a crucial part in ensuring the safety and quality of patient monitoring devices. Your day-to-day responsibilities will involve leading testing projects, collaborating with external agencies, and guiding teams to uphold the highest safety standards.

Requirements

• •At least 5-10 years of industry experience
• •Deep knowledge of product safety standards (IEC 60601-1, IEC60601-1-x, IEC/ISO 60601-2-xx, IEC/ISO80601-2-xx)
• •Deep knowledge of relevant regulations (UL, FDA, CSA, IEC, GB)
• •Experience with patient monitoring devices
• •Knowhow of design control processes for medical device design
• •System thinking mindset and domain expertise
• •Ability to manage and prioritize multiple projects
• •Outstanding communication skills
• •Proven leadership in project management
• •International perspective and eagerness to collaborate
• •Structured and self-organized
• •Good team player and ability to work independently

Tasks

• •Serve as the subject matter expert on product safety standards
• •Lead and manage complex system testing projects
• •Ensure compliance with safety and regulatory requirements
• •Act as the primary liaison with external safety test agencies
• •Develop and maintain documentation of test procedures and results
• •Guide cross-functional teams in integrating product safety considerations